Sneha Iyer

Experience

• 

  Watson Pharma Pvt Ltd

  May 2008 - Jun 2008

  Trainee

  • Trained under all the departments entailing the journey of an NSAID tablet right from its API manufacturing to packaging in a US-FDA approved facility.• Special focus on Formulation, tableting, processing, film coating, analysis, packaging of NSAID tablets for the US market.• Assisted in making Standard Operating Procedures for aseptic area, basic instruments like pH meter, microbalances, UV, HPLC• Assisted in generating Batch Manufacturing Records and carrying out IPQC• Presented report on the same with special emphasis on introductory Intellectual Property rights/ Patent and US FDA Regulations (Orange book, CTD Modules, ANDA, 505(b)(2) NDA filings, Para 4 filing etc) Show less

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  PRIN. K M Kundnani College of Pharmacy - University of Mumbai

  Jun 2009 - Apr 2011

  Teaching Assistant

  • Assisted Professors from the Pharmaceutics department in taking laboratory course-works in pharmaceutics (formulation), cosmetics, analysis and physical pharmacy.• Responsibilities included preparing reference samples, physical and quality analysis, editing of journals and assignments, giving presentations and assisting in grading students.

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  Grow Well Education

  Aug 2009 - Apr 2010

  Assistant Instructor & Marketing Executive

  • Classroom coaching for (Graduate Aptitude Test for Engineering) GATE now GPAT (Graduate Pharmacy Aptitude Test) aspirants on subjects like formulation, chemistry etc. for students aspiring to crack the M.S. entrance exam.• Assist in designing the coursework and marketing strategies for the organization. Gained experience in website management and back end basic data management of online content.• Marketing experience: Improved and influenced about 35% of student database in the batch. Show less

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  DR.MADHUKAR PHARMACEUTICALS PRIVATE LIMITED

  Jan 2012 - Jul 2013

  Project Manager

  Coordinating Technology Transfer:• Initiate meetings with technology providing scientists• Assisted in performing site-inspections. Drafting changes to the exclusivity agreements.• Coordinating and liaising with selected manufacturer for documents as required. • Developing reliable and sound vendors. • Handling and Supervising procurement, order placement and invoicing. • Marketing of products and identifying new end users. Improved the documentation and accountability of the same.QC/ QA:• Sample Management: Ensure adherence by testing through external approved agencies.• Interpretation of Analytical reports• Verify documents required for regulatory applications. Administrative responsibilities:• Organizing meetings between departments and with the new/existing suppliers, customers, independent testing agencies and contract manufacturers. Preparing and recording minutes for the same.• Supervising HR, Staff recruitment, monitoring as well as forming systems for documentation, Project Presentations and ad hoc communication activities.• Designing, proofreading and Supervision of Company Website and other Advertisement media.• Regulatory Skills: * Functional knowledge of the MHRA portal * Basic knowledge of the Modules, types of Procedures and Application, SmPC, ICH.* Registrations for ROW countries like China and Bangladesh. Responsible for Sourcing and Submission of Documents. Handled issuance and renewals for Licenses including Import Licenses * Work in regulated markets: Assisted in sourcing documents for CTD. Actively involved with the starting phase of registrations for regulated markets (US-FDA) and hence a sound theoretical knowledge of MAA and CTD requirements.* Provided training to juniors using Dummy DossiersTrained in eCTD, ICH-Q Show less

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  Brill Pharma Pvt Ltd. (Bristol Laboratories, UK)

  Oct 2014 - May 2016

  • Reported to the Director of Quality & Regulatory affairs. • Improved the quality of reports being sent to the MD & DirectorsProject Management - CMO's: • Single point of contact between CMO & upper management right from the stage of project inception to regular production. Monitor and manage the Technology transfer process and procurement of status updates/ data from the CMO’s on regular intervals and carry out trending of KPI’s to aid effective and timely management decisions. Adept at using MS office• Customer/ Vendor & Material Management (SAP)• Quality Assurance & Regulatory ActivitiesGap analysis of various Quality & Regulatory systems, Managing the regulatory and quality lifecycle of the WDL in-house licences, Performing document reviews, Submission of variation packages Show less

  • Coordination Executive (MD's Office) & Regulatory Affairs

    Jan 2015 - May 2016

  • Coordination Executive - MD's office

    Oct 2014 - Dec 2014
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  HegenLife Remedies Pvt Ltd

  Apr 2018 - now

  Director